Since the release of the New Dietary Ingredient (NDI) Draft Guidance in 2011, synthetic botanical constituents have been a hot topic. FDA has held steadfastly to its position that synthetic botanical constituents are not legal dietary ingredients because, in FDA’s view, they aren’t really “constituents” at all, as they were never “part of the plant.”

CRN has stalwartly maintained that synthetic versions of botanical constituents are legitimate dietary ingredients and FDA’s current position is inconsistent with the language of the Dietary Supplement Health and Education Act (DSHEA), the Congressional intent of the statute and FDA’s previous interpretations of the law. For example, FDA removed both synthetic ephedrine and natural ephedra from the market, maintaining that there was no difference between the two.

Each time CRN questions the agency, FDA has disregarded the legal arguments and repeated its unsupported mantra that “synthetics can’t be constituents” without addressing the overwhelming arguments against this interpretation.

Regardless of how this battle eventually plays out, perhaps as an industry, we can take some security from the possibility that there may be an alternative approach for getting those substances acknowledged as permissible dietary ingredients.

Here’s how. DSHEA provides a multi-pronged definition of a “dietary ingredient” in the law. You only need to meet one of the prongs of the definition to qualify; if you don’t meet one, maybe another will do. FDA’s current policy to exclude synthetic botanical constituents is based on the position that a synthetically made substance is not “an herb or other botanical,” nor is it “a concentrate, metabolite, constituent, extract or combination of” an herb or botanical. But there is another prong of the definition that just might work instead. A dietary ingredient can also be “a dietary substance for use by man to supplement the diet by increasing the total dietary intake.” This prong doesn’t say anything about the source of the substance, whether it is man-made or naturally made. As long as the substance (in either form) was in the diet, and is now being used in a supplement (again, in either form) to increase the dietary intake, it should be a legitimate ingredient.

For example, is EGCG from green tea a botanical constituent, a dietary substance or both? Based on FDA’s interpretation, synthetic EGCG might not qualify as a botanical constituent, but it certainly is a dietary substance being used to increase the total dietary intake. What about Allicin from garlic or lycopene from tomatoes? Last time I checked, tomato and garlic are botanicals, but FDA would say that a synthetic version of allicin or lycopene wouldn’t qualify as botanical constituents. However, if we call them dietary substances for which we are increasing dietary intake, they could still be used in supplements.

Confused? Stakeholder understanding of these definitional concepts remains murky at best and anxiety runs high about potential enforcement. I have been informally polling industry colleagues about which ingredients on the market they believe we risk losing if FDA does not change its position. There are a few obvious ones, like vinpocetine from the lesser periwinkle plant (a botanical without much history as a dietary substance), but many ingredients fall into the area outlined above.

One thing is for sure: this issue should be handled independently from the remainder of the NDI Draft Guidance, as it isn’t really about NDIs, nor is it related to safety. Because FDA’s objection is definitional, it is an a priori matter. It denies manufacturers the opportunity to present their safety data and denies consumers access to ingredients for no apparent reason.

CRN has been fighting to preserve the legal status of synthetic constituents as a matter of principle, but the outlook may not be so grim for some individual ingredients. Each firm should evaluate for itself what ingredients it is at risk of losing.

Tell me: what concerns do you have about this issue, and more specifically, what synthetic botanical constituents are you worried the industry might lose? Can many of them simply be recast as dietary substances? Feel free to respond to dmackay@crnusa.org.

Duffy MacKay, ND, is vice president, Scientific and Regulatory Affairs, for the Council for Responsible Nutrition, the dietary supplement industry’s leading trade association.

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The ideas and opinions expressed in this article are those of the author and do not necessarily reflect views held by Nutraceuticals World.

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